Feasibility of Collecting Quality of Life Data in Collaboration With the Stem Cell Therapeutic Outcomes Database (09-SQOL)

This study has been completed.

Sponsor:

Collaborator:

Medical College of Wisconsin

Information provided by (Responsible Party):

Center for International Blood and Marrow Transplant Research

ClinicalTrials.gov Identifier:

NCT01353677

First received: May 12, 2011

Last updated: July 24, 2017

Last verified: July 2017

History of Changes

Purpose

This is a multi-institution, non-randomized, prospective pilot study to evaluate the feasibility of collecting quality of life (QOL) data on a large cohort of pediatric and adult allogeneic Hematopoietic stem cell transplantation (HCT) recipients.

Condition
Hematopoietic Stem Cell Transplantation


Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Pilot Study to Assess the Feasibility of Collecting Quality of Life Data in Collaboration With the Stem Cell Therapeutic Outcomes Database

Further study details as provided by Center for International Blood and Marrow Transplant Research:


Enrollment:	390
Actual Study Start Date:	July 2011
Study Completion Date:	October 30, 2014
Primary Completion Date:	October 30, 2014 (Final data collection date for primary outcome measure)

Groups/Cohorts
HSCT recipients Adult (≥ 18 years), or pediatric (≥ 2 years and < 18 years) allogeneic HCT recipient (related, unrelated, or CBU) at participating pilot study transplant centers. Signed informed consent form from adult patient or parent/guardian of pediatric patient. Patient must have a valid mailing address within the United States to receive QOL surveys. Ability to speak and read English. Patients with access to a telephone.

Groups/Cohorts

HSCT recipients

Adult (≥ 18 years), or pediatric (≥ 2 years and < 18 years) allogeneic HCT recipient (related, unrelated, or CBU) at participating pilot study transplant centers.
Signed informed consent form from adult patient or parent/guardian of pediatric patient.
Patient must have a valid mailing address within the United States to receive QOL surveys.
Ability to speak and read English.
Patients with access to a telephone.

Detailed Description:

QOL data will be collected at baseline (pre-transplant), 100 days, 6 months, and 12 months post transplant. The transplant center will consent the patient and administer the baseline QOL surveys. The transplants center will then submit the competed baseline data and patient contact information to the Center for International Blood and Marrow Transplant Research (CIBMTR). The remaining surveys will be administered to the patient from the CIBMTR via paper surveys mailed to the patient.

Eligibility


Ages Eligible for Study:	2 Years and older (Child, Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

Pediatric and adult allogeneic HCT recipients

Criteria

Inclusion Criteria:

Adult (≥ 18 years), or pediatric (≥ 2 years and < 18 years) allogeneic HCT recipient (related, unrelated, or CBU) at participating pilot study transplant centers.
Signed informed consent form from adult patient or parent/guardian of pediatric patient.
Patient must have a valid mailing address within the United States to receive QOL surveys.
Ability to speak and read English.
Patients with access to a telephone.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01353677

Locations


United States, Florida
University of Florida
Gainesville, Florida, United States, 32610
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
University Hospitals of Cleveland
Cleveland, Ohio, United States, 44106
Cleveland Clinic
Cleveland, Ohio, United States, 44195
United States, Washington
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109

Sponsors and Collaborators

Center for International Blood and Marrow Transplant Research

Medical College of Wisconsin

Investigators


Principal Investigator:	Douglas Rizzo, MD, MS	CIBMTR/ Medical College of Wisconsin

More Information


Responsible Party:	Center for International Blood and Marrow Transplant Research
ClinicalTrials.gov Identifier:	NCT01353677 History of Changes
Other Study ID Numbers:	09-SQOL
Study First Received:	May 12, 2011
Last Updated:	July 24, 2017

Keywords provided by Center for International Blood and Marrow Transplant Research:


Hematopoietic stem cell transplantation QOL

ClinicalTrials.gov processed this record on September 19, 2017

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